Hepatoprotective Effects of Reishi Mushroom- (Ganoderma Lucidum) Among Metabolic Dysfunction-associated Fatty Liver Disease Patients

This 12-week RCT investigates the hepatoprotective and immunomodulatory effects of Ganoderma lucidum combined with a probiotic-rich diet in adults with MAFLD, assessing liver enzymes, lipid profile, inflammation, gut microbiota, and oxidative stress.

Findings are expected to show dose-dependent improvements in hepatic fat, insulin resistance, and inflammatory markers, potentially reducing reliance on pharmacotherapy in

Study Overview

• Status: Recruiting
• Conditions: Lipid Profile; Liver Biomarkers
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: reishi mushroom- (Ganoderma lucidum); Dietary supplement: Reishi mushroom dried powder; Dietary supplement: Reishi mushroom dried powder

Detailed Description

This study evaluates the therapeutic potential of (Ganoderma lucidum), combined with a probiotic-rich diet, to impose immunomodulatory and hepatoprotective effects in adults (35-65 years old) diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD). A 12-week randomized controlled trial (RCT) will be conducted, enrolling participants into three arms: a control group (starch capsules) and two intervention groups receiving either 250 mg or 500 mg of standardized Reishi extract daily. Primary outcomes include improvements in liver function markers (ALT, AST, ALP), lipid metabolism (LDL-C, HDL-C, triglycerides), and inflammatory biomarkers (CRP, IL-6). Secondary outcomes will assess gut microbiota composition (via 16S rRNA sequencing) and oxidative stress markers). Preliminary evidence suggests the Reishi-probiotic combination may significantly reduce hepatic fat accumulation (p<0.05) and serum LPS levels while increasing beneficial gut bacteria (e.g., Bifidobacterium spp.). We anticipate dose-dependent improvements in HOMA-IR scores and NF-κB suppression, correlating with triterpenoid bioavailability. If validated, this intervention could reduce reliance on pharmacotherapies by 30-40% in early-stage MAFLD, with synergistic effects observed between Beta-glucans and probiotic strains.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sana Noreen, PhD; Phone Number: 03018661160; Email: sananoreen.rizwan@gmail.com

Study Locations

• Pakistan
  • Lahore, Pakistan, 54000
    • Recruiting
    • Sana Noreen
    • Contact: Sana Noreen, PhD; Phone Number: 03018661160; Email: sananoreen.rizwan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults aged 35-65 years
• BMI between 18.5 and 30 kg/m².
• Complete Blood Count test ranges, WBC < 4,000-11,000 cells/µL, RBC Men < 4.5-6.0 / Women 4.0-5.5 million/µL, Hemoglobin: Men < 13.5-17.5 / Women 12.0-15.5 g/dL, Platelets < 150,000-450,000 cells/µL.
• Lipid profile test markers (elevated LDL, total cholesterol, or triglycerides less than 150mg/dL high 200-499mg/dL and 500 mg/dL are above high.
• Liver function test markers, ALT > 56 U/L, AST>40 U/L, ALP>147 UL.
• Inflammatory markers: CRP >3 mg/L, - IL-6 ≥3 pg/mL, TNF-α ≥8 pg/mL.
• Elevated blood sugar levels, or hyperglycemia, refer to a typically above 126 mg/dL, fasting or 200 mg/dL post-meal.

Exclusion Criteria:

• ● Diagnosed with severe cardiovascular disease, liver failure, or renal impairment.

  • Pregnant or lactating women.
  • Individuals currently on statins, ezetimibe, PCSK9 inhibitors, or any other lipid-lowering therapy.
  • Allergic to mushrooms.
  • Diagnosed with celiac disease or other chronic gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis).
  • History of malignancy.
  • Participation in another clinical trial within the last 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Conventional Group (To); starch capsules	Dietary supplement: Placebo; STARCH CAPCULE
Experimental: Experimental Group (T1); Each capsule contains 250 mg of Reishi mushroom dried powder, to be taken alongside a probiotic-rich diet.	Dietary supplement: reishi mushroom- (Ganoderma lucidum); Each capsule contains 250 mg of Reishi mushroom dried powder, to be taken alongside a probiotic-rich diet.; Dietary supplement: Reishi mushroom dried powder; Reishi mushroom dried powder ONCE A DAY; Dietary supplement: Reishi mushroom dried powder; Reishi mushroom dried powder TWICE A DAY
Experimental: Experimental Group (T2); Each capsule contains 250 mg of Reishi mushroom dried powder, to be taken twice alongside a probiotic-rich diet.	Dietary supplement: reishi mushroom- (Ganoderma lucidum); Each capsule contains 250 mg of Reishi mushroom dried powder, to be taken alongside a probiotic-rich diet.; Dietary supplement: Reishi mushroom dried powder; Reishi mushroom dried powder ONCE A DAY; Dietary supplement: Reishi mushroom dried powder; Reishi mushroom dried powder TWICE A DAY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LIPID PROFILE	Fasting blood samples will be collected at baseline and post-intervention to measure serum levels	12 WEEKS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver enzymes	Alanine Aminotransferase (ALT): Assessed using validated methods; Aspartate Aminotransferase (AST): Measured according to established protocols; Alkaline Phosphatase (ALP): Activity determined using outlined methods	12 weeks

Collaborators and Investigators

• Sponsor: University of Lahore

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2025
• Primary Completion (Actual): February 1, 2026
• Study Completion (Estimated): April 15, 2026

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: UOL/IREB/25/13/0059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No